Optimizing Uptake of Methylaminolevulinat With Fractional Ablative Laser Technique

The objectives of this study is to investigate if pre-treating the skin with an ablative fractional laser that creates small micropores in the skin:

1. Increases the uptake of Methylaminolevulinat (MAL) in the skin.
2. Decreases the required incubation time of MAL when performing photo dynamic therapy.

Study Overview

• Status: Completed
• Conditions: Photodynamic Therapy; Ablative Fractional Laser
• Intervention / Treatment: Procedure: Laser+Methylaminolevulinat

Detailed Description

12 healthy male individuals were included.

On the back, 25 areas measuring 2.8x2.8 cm were marked, plus one control area. We tested 2 variables.

1) Density of laser channels. 2) Methylaminolevulinat (MAL) concentration

1. Laser - Each area was randomized to receiving:

   • no treatment
   • 1% laser channel density
   • 2% laser channel density
   • 5% laser channel density
   • 10% laser channel density
   • 15% laser channel density

2. MAL - Each density was assigned to 4 areas. Within each density category, the four areas were randomized to receive:

   • vehicle
   • 4% MAL
   • 8%MAL
   • 16%MAL

The uptake of MAL was evaluated by fluorescence intensity measured with a florescence camera at t=

• 0min
• 30min
• 1h
• 1.5h 2h 2.5h 3h

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, DK-2400
    • Department of Dermatology, Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Male
• >18 years old
• Fitzpatrick skin type I-III
• No UV exposure thee months prior to study
• Signed study consent

Exclusion Criteria:

• Known allergy to substances in MAL or Unguentum M cream.
• Previous keloid
• Use of topical or systemic photosensitizing drug
• Evaluated to not be able to follow treatment protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser+Methylaminolevulinat; It's a single arm. Intervention as described in the detailed description.	Procedure: Laser+Methylaminolevulinat; It's a single arm study. Intervention as described in detailed description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluorescence Intensity	Fluorescence Intensity measured with a fluorescence camera.	up to 3 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin reactions	Evaluating skin reactions.	24h

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Investigators: Principal Investigator: Merete Haedersdal, MD PhD, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: December 20, 2012
• First Submitted That Met QC Criteria: December 24, 2012
• First Posted (Estimate): December 25, 2012

Study Record Updates

• Last Update Posted (Estimate): July 28, 2015
• Last Update Submitted That Met QC Criteria: July 25, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: H-4-2012-041